Establishment of User Fees for filovirus testing

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PART 51—REQUIREMENTS FOR
PREPARATION, ADOPTION, AND
SUBMITTAL OF IMPLEMENTATION
PLANS
1. The authority citation for part 51
continues to read as follows:

■

Authority: 42 U.S.C. 7401, 7411, 7412,
7413, 7414, 7470–7479, 7501–7508, 7601,
and 7602.
§ 51.100—[Amended]

2. Section 51.100 is amended at the
end of paragraph (s)(1) introductory text
by removing the words ‘‘methyl acetate,
1,1,1,2,2,3,3-heptafluoro-3-methoxypropane (n-C3F7OCH3, HFE–7000), 3ethoxy- 1,1,1,2,3,4,4,5,5,6,6,6dodecafluoro-2-(trifluoromethyl) hexane
(HFE–7500), 1,1,1,2,3,3,3heptafluoropropane (HFC 227ea),
methyl formate (HCOOCH3), (1)
1,1,1,2,2,3,4,5,5,5-decafluoro-3methoxy-4-trifluoromethyl-pentane
(HFE–7300); propylene carbonate;
dimethyl carbonate; trans-1,3,3,3tetrafluoropropene; and perfluorocarbon
compounds which fall into these

■

classes:’’ and adding in their place the
words ‘‘methyl acetate; 1,1,1,2,2,3,3heptafluoro-3-methoxy-propane (nC3F7OCH3, HFE–7000); 3-ethoxy1,1,1,2,3,4,4,5,5,6,6,6-dodecafluoro-2(trifluoromethyl) hexane (HFE–7500);
1,1,1,2,3,3,3-heptafluoropropane (HFC
227ea); methyl formate (HCOOCH3);
1,1,1,2,2,3,4,5,5,5-decafluoro-3methoxy-4-trifluoromethyl-pentane
(HFE–7300); propylene carbonate;
dimethyl carbonate; trans-1,3,3,3tetrafluoropropene; HCF2OCF2H (HFE–
134); HCF2OCF2OCF2H (HFE–236cal2);
HCF2OCF2CF2OCF2H (HFE–338pcc13);
HCF2OCF2OCF2CF2OCF2H (H-Galden
1040x or H-Galden ZT 130 (or 150 or
180)); and perfluorocarbon compounds
which fall into these classes:’’.

Approval and Promulgation of
Implementation Plans; New Mexico;
Albuquerque/Bernalillo County:
Infrastructure and Interstate Transport
Requirements for the 1997 and 2008
Ozone and the 1997 and 2006 PM2.5
NAAQS

[FR Doc. 2013–03057 Filed 2–11–13; 8:45 am]

§ 52.1620

BILLING CODE 6560–50–P

Due to an error in the EPA approval
date, the table entitled ‘‘EPA–
APPROVED ALBUQUERQUE/
BERNALILLO COUNTY, NM
REGULATIONS’’ on pages 58034 and
58035 is being reprinted in its entirety
to read as follows:

ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R06–OAR–2009–0648; FRL–9728–7]

Correction
In rule document 2012–22975
beginning on page 58032 in the issue of
Wednesday, September 19, 2012, make
the following corrections:

■

[Corrected]

EPA-APPROVED ALBUQUERQUE/BERNALILLO COUNTY, NM REGULATIONS
State citation

State
approval/effective date

Title/subject

EPA approval date

Explanation

New Mexico Administrative Code (NMAC) Title 20—Environment Protection, Chapter 11—Albuquerque/Bernalillo County Air Quality
Control Board
*

*

Part 8 (20.11.8 NMAC) ...........

*

*

*

Ambient Air Quality Standards.

*

Part 61 (20.11.61 NMAC) .......

*

*

*

8/12/2009

*

*

*

[FR Doc. C1–2012–22975 Filed 2–11–13; 8:45 am]
BILLING CODE 1505–01–D

1/10/2011

*

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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RIN 0920–AA47

Establishment of User Fees for
Filovirus Testing of Nonhuman Primate
Liver Samples
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).

AGENCY:

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ACTION:

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Final rule.

The Centers for Disease
Control and Prevention (CDC), located
within the Department of Health and
Human Services (HHS), is amending
regulations for the importation of live
nonhuman primates (NHPs) by
establishing a user fee for filovirus
testing of all nonhuman primates that
die during the HHS/CDC-required 31day quarantine period for any reason
other than trauma. We are amending the
regulations to establish a filovirus
testing service at HHS/CDC, because

SUMMARY:

[Docket No. CDC–2012–0002]

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September 19, 2012, [Insert
FR page number where
document begins].

42 CFR Part 71

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September 19, 2012, [Insert
FR page number where
document begins].
*

Prevention of Significant Deterioration.

*

*

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Federal Register / Vol. 78, No. 29 / Tuesday, February 12, 2013 / Rules and Regulations
testing is no longer being offered by the
only private, commercial laboratory that
previously performed these tests. This
testing service will be funded through
user fees.
DATES: This final rule is effective on
March 14, 2013.
FOR FURTHER INFORMATION CONTACT:
Ashley A. Marrone, J.D., Division of
Global Migration and Quarantine,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE.,
Mailstop E–03, Atlanta, Georgia 30333,
telephone, 404–498–1600.
SUPPLEMENTARY INFORMATION: This final
rule is organized as follows:
Table of Contents
I. Background
II. Public Comment Summary and Responses
A. Public Comments of General Support
B. Public Comments Regarding Analysis of
the Rule
III. Alternatives Considered
IV. Payment Instructions
V. Regulatory Analyses
A. Required Regulatory Analyses under
Executive Orders 12866 and 13563
B. Regulatory Flexibility Act
C. Small Business Regulatory Enforcement
Fairness Act of 1996
D. Paperwork Reduction Act of 1995
E. National Environmental Policy Act
(NEPA)
F. Civil Justice Reform (Executive Order
12988)
G. Executive Order 13132 (Federalism)
H. Plain Language Act of 2010

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I. Background
On February 10, 2012, we published
a notice of proposed rulemaking
(NPRM) in the Federal Register (77 FR
7109) that provided the background,
rationale, description of the services and
activities covered by the user fee, an
analysis of the user fee charge (cost to
the government), and payment
instructions. On the same date, we
published a companion Direct Final
Rule (DFR) (77 FR 6981). In both the
NPRM and DFR, we stated that if we did
not receive any significant adverse
comments by April 10, 2012, we would
publish a document in the Federal
Register withdrawing the NPRM and
confirming the effective date of the DFR
within 30 days after the end of the
comment period.
Because the DFR contained an error in
effective date and HHS/CDC received a
significant adverse public comment, we
published a correcting amendment in
the Federal Register on June 15, 2012
(77 FR 35878), withdrawing the DFR.
II. Public Comment Summary and
Responses
HHS/CDC received four public
comments on the NPRM. Three of the

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commenters expressed strong support
for the proposal, and one commenter
questioned our analysis of the rule.
HHS/CDC did not receive any public
comments objecting to the amount of
the user fee, which is $540.00 USD. The
comments and HHS/CDC responses are
summarized below.
A. Public Comments of General Support
One commenter indicated that the
user fees would be a good idea because
the testing of nonhuman primate liver
samples for filovirus infection is
essential for public health and safety.
The commenter stated that the amount
of the user fee is not exorbitant and will
allow the government to continue to test
NHPs. This commenter also expressed
concern that the agency would be
unable to continue to test NHPs absent
reimbursement. Finally, the commenter
indicated his/her support for the testing
of animals that pose a threat to human
life. A second commenter noted that it
is the duty of the federal government to
protect the health and welfare of its
citizens from preventable dangers and
that failure to do so would constitute a
dereliction of duty. Further, this
commenter fully supported what he/she
referred to as a ‘‘reasonable fee.’’
HHS/CDC Response. HHS/CDC
thanks the commenters for their
comments.
A third commenter agreed that
establishing user fees for filovirus
testing of nonhuman primate liver
samples was a necessary step toward
protecting public health. While this
commenter offered ‘‘100%’’ support for
the regulation, the commenter also
questioned whether HHS/CDC’s costs
for storing records could increase the
amount of the user fee in the future.
HHS/CDC Response. Although HHS/
CDC has only recently begun to offer
this testing service, it has collected and
maintained filovirus test results from
importers since the beginning of the
testing requirement and expects to
continue do so in the future. Because
maintaining test results are an expense
that HHS/CDC had already assumed,
these costs were not included in the
calculations of the user fee. HHS/CDC
does not expect to attempt to recoup
these costs in the future.
B. Public Comments Regarding Analysis
of the Rule
A commenter stated that CDC did not
provide an analysis of the filovirus
testing market, including the nature and
extent of current and future demand for
filovirus testing. The commenter
requested that HHS/CDC consider and
address the long-term prospects of the
filovirus testing market. Specifically, the

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commenter stated that if the market is
minimal, it would be appropriate for the
government to administer and perform
the testing. On the other hand, if the
market was much larger, then it may be
in the interest of the public and the
government to incentivize the
construction of private laboratory
facilities for the purpose of filovirus
testing, thereby allowing the
commercial market to serve the need of
importers.
HHS/CDC Response. HHS/CDC
disagrees with this comment. While not
labeled specifically as a market analysis
in the NPRM, the components of a
market analysis were included in the
preamble of the NPRM. Demand and
market size, as calculated by revenues
and numbers of requests for filovirus
tests, were included in section III
‘‘Rationale for Proposal’’ of the NPRM
and were based on the observed demand
noted by, and fees charged by, the
commercial laboratory that performed
this service since 1990.
In section VI ‘‘Analysis of User Fee
Charge (Cost to the Government)’’ of the
NPRM, HHS/CDC noted that during the
past five years, our records indicated
that there were approximately 100–150
requests per year, generating revenues of
$50,000 to $75,000 a year.
The issue of future demand was also
implicitly addressed in the NPRM,
where we noted that the demand for
testing is driven by government
requirements and the population of
imported NHPs that drive the demand is
limited by regulation to scientific,
exhibition or educational purposes.
Thus, we do not expect that market size
and demand will change substantially
in the long run.
Regarding the commenter’s query
about the size of the market, we note
that regardless of whether the filovirus
testing market is measured by requests
(100–150) or revenues ($50,000 to
$75,000 a year), it is, and will continue
to be, a small market from a laboratory
perspective. The market revenue
generated by testing is too small to
create demand specifically for a
‘‘filovirus testing facility’’ because
laboratories, especially the Biosafety
Level 4 (BSL–4) laboratories needed for
this type of testing, require large
amounts of sunk capital. In this context,
‘‘sunk capital’’ is intended to mean
investments in laboratory-specific
equipment and facilities that cannot be
resold for other businesses or used for
other purposes. As explained in the
NPRM, the testing procedure requires a
BSL–4 laboratory for specimen
processing, reagent preparation, and the
testing procedure. The forecast revenues
from filovirus testing of $50,000 to

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$75,000 a year would only be a fraction
of the budget needed to sustain a BSL–
4 type of facility needed to test for
filoviruses.
We note that the estimates in the
NPRM of a per-test cost of $540.00 USD
do not take into account the perspective
of a commercial laboratory that would
trade the costs and benefits of devoting
laboratory space and resources to
filovirus testing for other revenuegenerating tests and services they could
offer. Finally, we note that no
commercial entities have entered the
market of antigen-capture filovirus
testing since the original commercial
laboratory stopped providing this
service.
Viewed as a whole, these factors
(sunk capital required to perform such
testing, limited market demand, and
current lack of a commercial laboratory
offering this service), were instrumental
in shaping our view that there is likely
no commercial laboratory that will enter
this market in the immediate future.
However, as indicated in the NPRM,
nothing in this final rule prohibits a
commercial laboratory from entering the
market in the future.
Next, the commenter raised a series of
questions regarding long run actions
that CDC can take to make filovirus
testing viable commercially.
Specifically, the commenter said, ‘‘it
may be more appropriate to examine the
data and other indicators to ensure that
the agency is not overlooking any
externalities.’’
HHS/CDC Response. As noted in the
NPRM, there are no private laboratories
engaged in filovirus testing at this time.
If HHS/CDC were to provide the tests
free-of-charge, this would be a long-term
disincentive for any commercial lab to
enter the business because no
commercial lab could compete with nofee testing. By implementing a fee, CDC
is eliminating the nature of unfair
government competition created by a
price that may be below standard
commercial market fees, or free. The fee
HHS/CDC intends to charge is
consistent with the fee previously
charged by the one commercial
laboratory performing this type of
testing. Furthermore, as HHS/CDC
stated in the NPRM and above, the
action taken in this rulemaking is not
intended to prohibit a private sector
facility from developing the capability
and offering this same service in the
future. When considered together, the
fee, the extensive investments needed to
build and maintain BSL–4 type
laboratories, and the small size of the
filovirus testing market, indicate that
CDC can take no other short-term or

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long-term actions to encourage a private
market for filovirus testing.
III. Alternatives Considered
As stated earlier in the Preamble,
HHS/CDC believes this testing is
essential to protect public health and
safety. If this testing is not provided, it
will have a disruptive impact on
imports of NHPs for science,
educational, and exhibition purposes,
that would remain in quarantine absent
a negative test result.
When HHS/CDC learned that the sole
commercial laboratory performing this
testing was no longer offering the
testing, we considered several
alternatives to meet the testing
requirement. One alternative was to
wait for another commercial laboratory
to begin performing the testing.
However, as stated previously in the
Preamble, another laboratory has not
entered the market since the previous
laboratory stopped performing this
testing. Indeed, to date, no laboratory
has begun offering this service in
response to the NPRM.
Another alternative that HHS/CDC
considered was to perform the testing in
HHS/CDC laboratories at no cost.
However, as commenters have noted,
the cost burden of performing the
testing without compensation may
prevent the Agency from performing the
testing indefinitely. Further, as we
stated previously in the Preamble,
should HHS/CDC offer this testing at no
charge, it would create a disincentive to
the private sector to enter the market.
Finally, HHS/CDC considered offering
a filovirus testing service and
establishing a user fee to cover the cost
of the testing. This is the alternative that
HHS/CDC chose.
IV. Payment Instructions
As of the effective date of this rule,
importers should submit a check or
money order in the amount of $540.00
USD made payable to Centers for
Disease Control and Prevention for each
test conducted at the time that
specimens are submitted to the CDC for
testing. The check(s) should be sent to
Centers for Disease Control and
Prevention, P.O. Box 15580, Atlanta, GA
30333.
V. Regulatory Analyses
A. Required Regulatory Analyses Under
Executive Orders 12866 and 13563
We have examined the impacts of the
final rule under Executive Orders 12866
and 13563, which direct agencies to
assess all costs and benefits of available
regulatory alternatives and, when
regulation is necessary, to select

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regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety, and other advantages,
distributive impacts, and equity).
Because the purpose of this rule is to
provide a framework to determine a fair
fee to charge for a service that has
become unavailable in private,
commercial markets within the United
States, we have determined that the rule
will not violate the intent of either of
the Executive Orders because it will in
no way prevent a private entity from
entering the field and providing a
similar, privatized service. If any private
entity expresses an interest in providing
this service, we strongly encourage them
to do so.
This rule is being treated as ‘‘not
significant’’ under EO 12866. We are
amending 42 CFR 71.53 to establish a
filovirus testing service at HHS/CDC,
because testing is no longer being
offered by the only private, commercial
laboratory that previously performed
these tests. Thus, the rule has not been
reviewed by the Office of Management
and Budget (OMB).
B. Regulatory Flexibility Act
We have examined the impacts of the
final rule under the Regulatory
Flexibility Act (5 U.S.C. 601–612).
Unless we certify that the rule is not
expected to have a significant economic
impact on a substantial number of small
entities, the Regulatory Flexibility Act
(RFA), as amended by the Small
Business Regulatory Enforcement
Fairness Act (SBREFA), requires
agencies to analyze regulatory options
that would minimize any significant
economic impact of a rule on small
entities. We certify that this rule will
not have a significant economic impact
on a substantial number of small entities
within the meaning of the RFA.
C. Small Business Regulatory
Enforcement Fairness Act of 1996
This regulatory action is not a major
rule as defined by Sec. 804 of the Small
Business Regulatory Enforcement
Fairness Act of 1996. This final rule will
not result in an annual effect on the
economy of $100,000,000 or more; a
major increase in cost or prices; or
significant adverse effects on
competition, employment, investment,
productivity, innovation, or on the
ability of United States-based
companies to compete with foreignbased companies in domestic and
export markets.

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Federal Register / Vol. 78, No. 29 / Tuesday, February 12, 2013 / Rules and Regulations
D. The Paperwork Reduction Act of
1995
HHS/CDC has reviewed the
information collection requirements of
the final rule and has determined that
the information collection requested in
the final rule is already approved by the
Office of Management and Budget
(OMB) under OMB Control No. 0920–
0263, expiration date June 30, 2014. The
final rule does not contain any new data
collection or record keeping
requirements.
E. National Environmental Policy Act
(NEPA)
Pursuant to 48 FR 9374 (list of HHS/
CDC program actions that are
categorically excluded from the NEPA
environmental review process), HHS/
CDC has determined that this action
does not qualify for a categorical
exclusion. In the absence of an
applicable categorical exclusion, the
Director, CDC, has determined that
provisions amending 42 CFR 71.53 will
not have a significant impact on the
human environment. Therefore, neither
an environmental assessment nor an
environmental impact statement is
required.
F. Civil Justice Reform (Executive Order
12988)
This final rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. Under this final rule: (1)
All State and local laws and regulations
that are inconsistent with this rule will
be preempted; (2) no retroactive effect
will be given to this rule; and (3)
administrative proceedings will not be
required before parties may file suit in
court challenging this rule.

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G. Executive Order 13132 (Federalism)
The Department has reviewed this
rule in accordance with Executive Order
13132 regarding Federalism, and has
determined that it does not have
‘‘federalism implications.’’ The rule
does not ‘‘have substantial direct effects
on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government.’’
H. Plain Language Act of 2010
Under Public Law 111–274 (October
13, 2010), executive Departments and
Agencies are required to use plain
language in documents that explain to
the public how to comply with a
requirement the Federal Government
administers or enforces. HHS/CDC
attempted to use plain language in
promulgating this rule consistent with
the Federal Plain Writing Act guidelines

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and requested comment from the public
on this topic. HHS/CDC did not receive
any public comment to this request.
List of Subjects in 42 CFR Part 71
Communicable diseases, Public
health, Quarantine, Reporting and
recordkeeping requirements, User fees,
Testing.
For the reasons discussed in the
preamble, the Centers for Disease
Control and Prevention amends 42 CFR
part 71 as follows:
PART 71—FOREIGN QUARANTINE
1. The authority citation for 42 CFR
part 71 continues to read as follows:

■

Authority: Sec. 311 of the Public Health
Service (PHS) Act, as amended (42 U.S.C.
243), secs. 361–369, PHS Act, as amended
(42 U.S.C. 264–272).

Subpart F—Importations
2. In § 71.53, add paragraph (j) to read
as follows:

■

§ 71.53

Nonhuman primates.

*

*
*
*
*
(j) Filovirus testing fee. (1) Nonhuman primate importers shall be
charged a fee for filovirus testing of nonhuman primate liver samples submitted
to the Centers for Disease Control and
Prevention (CDC).
(2) The fee shall be based on the cost
of reagents and other materials
necessary to perform the testing; the use
of the laboratory testing facility;
irradiation for inactivation of the
sample; personnel costs associated with
performance of the laboratory tests; and
administrative costs for test planning,
review of assay results, and
dissemination of test results.
(3) An up-to-date fee schedule is
available from the Division of Global
Migration & Quarantine, Centers for
Disease Control and Prevention, 1600
Clifton Road, Atlanta, Georgia 30333.
Any changes in the fee schedule will be
published in the Federal Register.
(4) The fee must be paid in U.S.
Dollars at the time that the importer
submits the specimens to HHS/CDC for
testing.

Dated: February 4, 2013.
Kathleen Sebelius,
Secretary, Department of Health and Human
Services.
[FR Doc. 2013–02825 Filed 2–11–13; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 67
[Docket ID FEMA–2013–0002]

Final Flood Elevation Determinations
Federal Emergency
Management Agency, DHS.
ACTION: Final rule.
AGENCY:

Base (1% annual-chance)
Flood Elevations (BFEs) and modified
BFEs are made final for the
communities listed below. The BFEs
and modified BFEs are the basis for the
floodplain management measures that
each community is required either to
adopt or to show evidence of being
already in effect in order to qualify or
remain qualified for participation in the
National Flood Insurance Program
(NFIP).

SUMMARY:

The date of issuance of the Flood
Insurance Rate Map (FIRM) showing
BFEs and modified BFEs for each
community. This date may be obtained
by contacting the office where the maps
are available for inspection as indicated
in the table below.
ADDRESSES: The final BFEs for each
community are available for inspection
at the office of the Chief Executive
Officer of each community. The
respective addresses are listed in the
table below.
FOR FURTHER INFORMATION CONTACT: Luis
Rodriguez, Chief, Engineering
Management Branch, Federal Insurance
and Mitigation Administration, Federal
Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,
(202) 646–4064, or (email)
[email protected].
DATES:

The
Federal Emergency Management Agency
(FEMA) makes the final determinations
listed below for the modified BFEs for
each community listed. These modified
elevations have been published in
newspapers of local circulation and
ninety (90) days have elapsed since that
publication. The Deputy Associate
Administrator for Mitigation has
resolved any appeals resulting from this
notification.
This final rule is issued in accordance
with section 110 of the Flood Disaster
Protection Act of 1973, 42 U.S.C. 4104,
and 44 CFR part 67. FEMA has
developed criteria for floodplain
management in floodprone areas in
accordance with 44 CFR part 60.

SUPPLEMENTARY INFORMATION:

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